The long-term efficacy of endoscopic/endoluminal gastroplasty or gastroplication with suturing of the esophagogastric junction has not yet been established. Therefore, endoscopic gastroplasty or gastroplication with suturing of the esophagogastric junction is considered experimental/investigational, and is not covered.  A participating, preferred, or network provider can bill the member for the denied service.

Description

Endoscopic gastroplasty, also referred to as gastroplication with suturing of the esophagogastric junction is a minimally invasive alternative to either open or laparoscopic gastric fundoplication as a treatment of gastroesophageal reflux disease (GERD). During the upper gastrointestinal endoscopy, the physician suctions two sections of the esophageal-gastric tissue into the suturing system, deploys a needle with a suture, and tightens a running suture through the two portions of captured tissue to form a pleat or internal plication. The sutures are placed in the lower esophageal sphincter, thereby creating a functional antireflex barrier. These plications are designed to strengthen and lengthen the sphincter in order to decrease reflux. The Bard EndoCinch Suturing System is an example of a device used in endoscopic gastroplasty with suturing. This procedure is generally performed outpatient, does not require general anesthesia and takes approximately 30-35 minutes.

The Sew-Right (Wilson-Cook, Winston-Salem, NC) device is another type of endoscopic suture system that forms plication folds between proximal gastric rugae.  This sewing procedure is reported to be easier and requires fewer repetitive steps to place a suture compared with similar methods.

A recent variation of the endoscopic suturing system is the NDO Transmural Plicator.  This plicator creates a transmural, full-thickness plication using a pre-tied, suture based implant that is delivered endoscopically just below the gastrointestinal junction (GEJ) in a retroflexed manner to accentuate and restore the valvular mechanism.  This procedure is reported to take approximately 20 minutes to perform.

The StomaphyX™ device was approved in March 2007 by the FDA through the 510(k) process. The FDA clearance indicated this device was equivalent to EndoCinch. The StomaphyX device is an endoluminal delivery system developed and manufactured by EndoGastric Solutions, Inc. It is indicated for use in endoluminal transoral tissue approximation and ligation in the gastrointestinal tract. Currently, the StomaphyX device is being used in the treatment of gastroesophageal reflux disease. It is also used in the treatment of weight gain after bariatric surgery to remedy a large gastric stoma or large gastric pouch. See Medical Policy G-24 for additional information on bariatric surgery for morbid obesity.

The EsophyX Transoral Incisionless Fundoplication was approved by the FDA in September 2007 for the treatment of symptomatic chronic GERD in patients requiring and not responding to antireflux medications. Similar to the NDO Plicator, the EsophyX device provides a full-thickness serosa-to-serosa to muscularis (depending on the approach) plication of the gastroesophageal junction. Unlike the NDO Plicator, this device will also allow reduction of a hiatal hernia of up to 2 cm and is designed to recreate the gastroesophageal valve by restoring the intraluminal extension of the angle of His and restoring intraabdominal length.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP.  Medical policy is not an authorization, certification, explanation of benefits or a contract.  Benefits are determined by the Federal Employee Program.

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